What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Digital Prospectors?
Position: Senior Quality Assurance Specialist
Location: Woburn, MA (Hybrid – 3 to 4 days onsite)
Length: 12 months
Job Description:
Our client is seeking a highly skilled Senior Quality Assurance (QA) Specialist to join their team. This is an exciting opportunity for an experienced professional to contribute to a culture of continuous improvement, collaboration, and high-quality standards. In this role, you will work closely with various departments, including Quality Control (QC), IT, and laboratory teams, to ensure smooth and compliant operations across multiple facilities.
Essential Duties and Responsibilities (but not limited to):
- Provide proactive support for site operations, including associated facilities, laboratory functions, and IT operations.
- Collaborate with QC teams and other support groups to ensure compliance with quality standards, particularly related to system changes.
- Review and approve analytical method validation protocols, reports, and data packages, ensuring adherence to required standards.
- Generate and approve Certificates of Analysis (COAs) in the Laboratory Information Management System (LIMS) to support batch release and regulatory filings.
- Review and approve deviations and change controls from an analytical QA perspective.
- Assist with site and departmental inspection readiness programs as necessary, ensuring preparation for audits and inspections.
- Provide guidance on quality systems, including data review processes, to maintain the health of the quality management framework.
- Apply risk management principles to enhance and continuously improve QC-related processes and procedures.
Qualifications:
- Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or a related field.
- At least 7 years of experience in Quality Assurance within a biopharmaceutical or biotechnology GMP setting, with a focus on Quality Control.
- Proven experience in both internal QC operations and external contract test lab operations is a plus.
- Strong knowledge of FDA and EMA regulations, with hands-on experience in the US and international regulatory agency inspections.
- Demonstrated ability to lead and participate in continuous improvement initiatives within a regulated environment.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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Job #17430
